阿达木单抗生物类似药的疗效与安全性：类风湿关节炎的当前关键临床数据
Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis.
作者信息
Lu XiaoQin, Hu Rui, Peng Lin, Liu MengSi, Sun Zhen
机构信息
School of Pharmacy and Laboratory Science, Ya'an Polytechnic College, Ya'an, China.
Hengyang Medical College, University of South China, Hengyang, China.
出版信息
Front Immunol. 2021 Apr 6;12:638444. doi: 10.3389/fimmu.2021.638444. eCollection 2021.
Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented. In this review, we summarized clinical trials of seven biosimilars currently approved by the FDA and/or EMA for the treatment of rheumatoid arthritis, namely: ABP 501 (Amjevita/Amgevita/Solymbic), BI 695501 (Cyltezo), SB5 (Imraldi/Hadlima), GP2017 (Hyrimoz/Hefiya/Halimatoz), MSB11022 (Idacio), FKB327 (Hulio), and PF-06410293 (Abrilada). Overall, these biosimilars showed similar efficacy, safety, and immunogenicity to adalimumab. All biosimilar switching trials indicated that switching from adalimumab to a biosimilar does not have a significant impact on efficacy, safety, and immunogenicity.
阿达木单抗作为一种用于治疗类风湿性关节炎的肿瘤坏死因子（TNF）抑制剂生物制剂，是全球最畅销的药物之一。随着其各项专利逐渐到期，对其生物类似药的试验正在不断开展。在本综述中，我们总结了目前已获美国食品药品监督管理局（FDA）和/或欧洲药品管理局（EMA）批准用于治疗类风湿性关节炎的七种生物类似药的临床试验，分别为：ABP 501（Amjevita/Amgevita/Solymbic）、BI 695501（Cyltezo）、SB5（Imraldi/Hadlima）、GP2017（Hyrimoz/Hefiya/Halimatoz）、MSB11022（Idacio）、FKB327（Hulio）以及PF-06410293（Abrilada）。总体而言，这些生物类似药在疗效、安全性和免疫原性方面与阿达木单抗相似。所有生物类似药转换试验均表明，从阿达木单抗转换为生物类似药对疗效、安全性和免疫原性没有显著影响。
Zotero 插件